PS3-05: Electronic Data Collection for a Clinical Trial Conducted within a Health System

摘要

>Background/Aims: Designing a seamless data collection tool for a research study across multiple physical locations within a health care system is challenging. Paper-based data collection is prone to data entry errors, subject to delays in availability of data, and environmentally wasteful. Web-based data collection tools are costly, time consuming to produce, and have security issues. We used Microsoft Access to create an efficient, low-cost electronic data collection tool for a clinical trial that required availability at numerous locations in the HealthPartners system.>Methods: The research study required data collection entry points at ten different locations for different types of users, all linked into the HealthPartners computer network. A single Access database with linked modules for recruitment, tracking, eligibility determination and data collection was designed.>Results: The recruitment module used at the research department integrated data on recruitment mailings and telephone screening of interested respondents, and used an automated algorithm to perform eligibility checks. The research clinic module for clinic visits was populated with eligible participants as determined by the recruitment module. This clinic module included further eligibility checks, data collection and treatment assignment. Participants then became available in the intervention module to pharmacist case managers located at 8 HealthPartners primary care clinics to collect data for the intervention. Based on study entry date, Access created a visit log to aid the case managers with timely adherence to the trial protocol. The database is stored on a secure server that is accessible only to authorized study team members, with further restrictions on data entry and access determined by study team role.>Conclusions: The disadvantages of Microsoft Access (lack of flexibility, “bugginess”, older technology) are counterbalanced by many advantages (ready availability, inexpensiveness, security, the ability to analyze data in real time). Research teams should consider these factors when designing electronic data collection tools.